Major accountabilities:

• Provides medical support to Clinical Program Leader (CPL) and / or Medical Expert. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables.
• May act as the medical monitor to support overall program safety reporting (e.g., Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team.
• Contributes to clinical/scientific elements of TCO – related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc.
• Contributes to the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation
• Supports conduct of dose escalation meetings, investigator teleconferences and site initiation visits etc.
• Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team
• Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies.
• Advocate continuous improvement of quality

Key performance indicators:

• Evidence of high-quality medical input to assigned studies to ensure execution according to timelines and ensuring adherence to international and local regulations.  
• Evidence of quality medical and scientific review of clinical trial data
• Demonstrates excellent scientific writing skills to enable the development of high-quality documents including but not limited to clinical trial protocols, trial reporting (e.g. CSR), and regulatory documents (e.g. IB, DSUR). 
• Contribution towards objectives set for the department.  
• Feedback from external and internal stakeholders.  
• Clearly demonstrates Novartis Values and Behaviors.  

Minimum Requirements:

• MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required.
• Experience in hematology / oncology preferred.

Work Experience:

• At least 2 years of pharmaceutical/biotech industry experience or at least 4 years of clinical practice experience in the hospital setting
• Knowledge of Good Clinical Practice (GCP). 
• Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. 
• Demonstrated operational excellence and scientific contribution to clinical or preclinical projects. 
• Clear written and verbal expression of ideas, an active/proactive communicator. 
• Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. 
• Used to working independently and in a team, being flexible and adapting in a changing environment. 

Skills:

• Clinical Monitoring.
• Clinical Research.
• Clinical Trial Protocol.
• Clinical Trials.
• Decision Making Skills.
• Drug Development.
• Health Sciences.
• Lifesciences.
• Regulatory Compliance.

Languages :

• English.